Medical Monitor

📋 Description

• Provide on-call medical coverage during Phase I screening, dosing.
• Review eligibility via history, exams, labs, ECGs, and criteria.
• Respond to medical emergencies and adverse events; escalate as needed.
• Participate in SRC meetings and dose-escalation decisions.
• Review real-time safety data to inform stopping rules and dose decisions.
• Communicate safety findings to Sponsors, PI, and IRB/EC as required.

🎯 Requirements

• MD or DO from an accredited medical school with active license.
• 5+ years clinical experience in a medical setting.
• 2+ years experience in clinical research, pharmacology, or CRO.
• Working knowledge of ICH-GCP, FDA regulations, and human subjects rules.
• Strong PK/PD understanding for dose-escalation decisions.
• Excellent written and verbal communication; ability to mentor and lead.